MINI-ZAFEN
-
Chemical Name:
Ketotifen -
Therapeutic Category:
Ophthalmic drugs -
Pharmacologic Category:
Histamine H1; Antagonist, Second Generation - Mast Cell Stabilizer -
Pharmaceutical Form:
Eye Drops - Single Dose -
Composition:
Ketotifen 0.1mg/ 0.4ml
MINI ZAFEN
Sterile Single Dose Eye Drops
Ketotifen (Fumarate)
1-INDICATIONS:
Symptomatic treatment of seasonal allergic conjunctivitis.
2-CONTRAINDICATIONS:
Hypersensitivity to ketotifen or to any of the excipients.
3-WARNINGS & PRECAUTIONS:
No special warning.
4-PREGNANCY & LACTATION:
There are no adequate data from the use of ketotifen eye drops in pregnant women. Caution should be exercised when prescribing to pregnant women.
Although animal data following oral administration show excretion into breast milk, topical eye drops can be used during lactation.
5-SIDE EFFECTS:
Eye disorders:
Common effects: Eye irritation, eye pain, punctuate keratitis.
Uncommon effects: Vision blurred (during instillation), dry eye, eyelid disorder, conjunctivitis, photophobia, conjunctival hemorrhage.
Nervous system disorders: Somnolence.
Skin and subcutaneous tissue disorders: Rash, eczema, urticaria.
Gastrointestinal disorders: Dry mouth.
Immune system disorders: Hypersensitivity.
6-DRUG INTERACTIONS:
If MINI ZAFEN is used concomitantly with other eye medications there must be an interval of at least 5 minutes between the medications.
The use of the oral dosage of ketotifen may potentiate the effects of CNS depressants, antihistamines and alcohol. Although it is not observed in MINI ZAFEN eye drops, the possibility of such effects cannot be excluded.
7-DOSAGE & ADMINISTRATION:
Adults, elderly and children (age 3 and older): One drop of MINI ZAFEN into the conjunctival sac twice a day. The contents of single-dose containers are sufficient for one administration into both eyes.
The contents remain sterile until the original closure is broken. To avoid contamination do not touch any surface with the tip of the container.
* Wash your hands.
* Open the pouch along the dashed line.
* Detach one single dose container from the strip.
* Put the remaining strip back in the pouch and fold the edge to close the pouch.
* Make sure that the solution is in the bottom part of the single dose container.
* To open the container, twist off the tab.
* Tilt your head backwards while seated, or lie down on your back.
* Place the tip of the container close to your eye.
* Pull the lower eyelid downwards and look up.
* Press the container slightly and let one drop fall into the space between the lower eyelid and the eye.
8-PACKAGING & COMPOSITION:
MINI ZAFEN - Single Dose Eye Drops: A pack of 10 or 30 plastic containers contain 0.4 mL of sterile solution as a singlr dose in external package. Each 0.4 mL contains Ketotifen Fumarate corresponding to 0.1 mg Ketotifene.
9-STORAGE:
Store at temperature (15- 25)°C.
